The US-based medical device company Medtronic will continue to provide clinically-proven and globally certified latest generation drug eluting stents subsequent to government invoking special powers under the law directing companies to maintain production, import and supply of coronary stents to avoid any shortage.

Spurred by the need for effective therapies in coronary artery disease (CAD), Medtronic had launched new drug-eluting stent (DES) technology Resolute Onyx for the first time in India in 2015. The technology is based on Resolute Integrity platform which offers flexibility in the form of sleek and narrow DES to be able to navigate into thinnest of the arteries imparting drug elution in an efficient way to avert restenosis.

“Medtronic will increase access of cardiovascular therapy to patients in India and cater to different needs of patients and physicians while providing them with a choice of clinically-proven and globally-certified stents like Resolute and Resolute Integrity,” Medtronic spokesperson in an email interaction with Pharmabiz.
 
The email further states, “It is important to note that Resolute Integrity which has been the first US FDA approved drug eluting stent for an additional indication on patients having diabetes mellitus with symptomatic ischemic heart disease, continues to be available in India.”

Medtronics had written to the National Pharmaceutical Pricing Authority (NPPA), asking permission for withdrawal of its drug eluting stent, Resolute Onyx. “We have submitted an application for withdrawal of Resolute Onyx (latest generation drug eluting stent) under the provisions of Drug Price Control Order. We will continue to supply Resolute Onyx till we get the required permissions from the authorities. Our decision to withdraw or introduce products is made only after taking into consideration all guidelines and norms set by the government,” stated in an email.

Over the past 20 years, stents have evolved from a plain vanilla bare metal stent to new generation DES. Resolute Onyx DES is a revolution in stent technology. Resolute Onyx is the most deliverable DES, featuring Core Wire Technology. It has thinner struts to help improve deliverability without compromising radial and longitudinal strength of the stent. Resolute Onyx has proven long-term safety and efficacy with increased risk for stent thrombosis with interruption or discontinuation of DAPT after 1 month. Resolute Onyx DES builds on the Resolute Integrity platform’s acute procedural success for even greater flexibility and conformability.

CoreWire Technology is the next new DES advancement after Continuous Sinusoid Technology (CST). Core Wire Technology combined with CST enables thinner struts without compromise in radiopacity or overall structural strength. Wrapped in a Cobalt Alloy shell, the denser, more radiopaque inner core material allows for improved visibility during procedure, referred to as radiopacity. The Cobalt alloy shell maintains the mechanical performance and structural strength of the stent material thus improving deliverability and acute performance.

Core Wire Technology is an exciting innovation that will have measurable impact on clinical practice today and tomorrow. The advancements of the Resolute Onyx DES specifically address the need for continued procedural efficiency and ease-of-use. Importantly, and in contrast to some current DES technologies, it achieves meaningful deliverability enhancement with no compromise to stent strength.

All the above features incorporated in the Resolute Onyx coronary stent system allows the stent to be at least 20 per cent more deliverable than the current generation DES.